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The 55 year old jogs, rides a racing bike, and eats carefully. As a result, he lives an almost pain free life. He is only occasionally afflicted with a sour stomach, for which each time his doctor prescribes a medicine against heartburn.
Luther himself hasn’t noticed his terrible pain at all. He looks as fit as anyone; he’s doing great. And if he wasn’t the chairman of the board of the same sickness fund by which he is covered as a patient, he might never have found out that his health situation had deteriorated so dramatically.
An asthma patient, who goes to the pneumonologist every second quarter and uses the conventional combination spray, provides a plus of €192 a year.
The diagnosis ‘psychological depression’ brings the sickness fund nothing. It’s better when the insured has a ‘light depressive episode,’ then there is almost €1000 extra.
WASHINGTON, D.C. (April 7, 2009) - Democratic and Republican party leaders and political operatives will discuss their differing perspectives on the challenges and opportunities associated with the comprehensive reform of the U.S. healthcare system during a keynote panel, titled "The Challenges and Opportunities Surrounding Healthcare Reform,” taking place Wednesday, May 20 from 12:00 – 1:45 pm at the Georgia World Congress Center during the Keynote Luncheon at the 2009 BIO International Convention.
Moderated by Susan Dentzer of The NewsHour with Jim Lehrer, the panel will include Senator Tom Daschle, Governor Howard Dean, Senator William H. Frist, M.D, and Karl Rove.
"This panel provides an opportunity to discuss and debate the best options and opportunities for the new administration as they move toward their goal of restructuring our nation's health care system,” said James C. Greenwood, president and CEO, BIO. "As the Obama Administration and Congress explore how to restructure the delivery of the nation's health care services, it is important that the biotech industry is involved in the debate.”
The panel will address the road to a new health care system in the United States, providing a preview to the debates expected to take place in Congress later this year. Panel members bring with them a vast array of experience in government service, from Congress to the Governorship and Chief of Staff to former President George W. Bush.
Great...that's exactly what we need. Spin from spinmeisters who will tell the assembled how to behave to get a "seat at the table." And I am sure they are all doing it for free. I hope BIO got a good deal on the car service at least...
And how does listening to the same stuff and talking points from the New America Foundation and Rahm Emanuel (at least as far as Daschle is concerned) going to insure that biotech is involved in the debate. Last time around biotech met face to face with President Clinton and the health proposal still called for comparative effectiveness reviews as a condition for reimbursement and use. Now it's a done deal and BIO is fine with it..... Have you seen those principles about "patient-centered" health care anywhere in the FCCER mission. Anyone?
I still think it is better to stand up for principles before getting a seat at the table....And it's a lot better to give politicians a piece of your mind than to have them lecture you about how to behave in The People's House... It is still ours...
If you like comparative effectiveness you’re going to love mental modeling.
In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.
Something to think about.
A Florida couple, both well into their 70s, go to a sex therapist's office.
The doctor asks, "What can I do for you?"
The man says, "Will you watch us have sexual intercourse?"
The doctor raises both eyebrows, but he is so amazed that such an elderly couple is asking for sexual advice that he agrees.
When the couple finishes, the doctor says, "There's absolutely nothing wrong with the way you have intercourse."
He thanks them for coming, he wishes them good luck, he charges them $50 and he says good bye.
The next week, the same couple returns and asks the sex therapist to watch again. The sex therapist is a bit puzzled, but agrees.
This happens several weeks in a row.
The couple makes an appointment, has intercourse with no problems, pays the doctor, then leave.
Finally, after 3 months of this routine, the doctor says, "I'm sorry, but I have to ask. Just what are you trying to find out?"
The man says,
"We're not trying to find out anything.
She's widowed and lives with a daughter so we can't go to her house. I'm widowed and live with my son and family so we can't go to my house.
The Holiday Inn charges $98. The Hilton charges $139. We do it here for $50, and I get $43 back from Medicare.”
At just before 5pm last Friday (April 3), the FDA posted 14 DDMAC warning letters. They can all be found here:
Click Here to Read the Letters
First of all, kudos to the agency for posting them so swiftly. The letters were all released on April 2 and posted on April 3.
DDMAC, timely? What’s wrong with this picture? Or, if you prefer, what’s right?
The next item to consider is the contents of the letters. They all deal with the same topic, “sponsored” Google links.
DDMAC consistent? What’s wrong with this picture? Of, if you prefer …
Consistent because all of the letters not only deal with the same issue of sponsored links, but address them in more or less the same way. Let’s take the letter to Bayer for example:
Here’s how the letter begins:
“The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored links for Mirena overstate the efficacy of the drug. Furthermore, all of the sponsored links fail to use the required established name. Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).”
While the particulars for each of the other 13 letters differ, the basic theme is the same, that the “sponsored links” are not in compliance because they are “misleading” – making “representations and/or suggestions” that DDMAC feels are out of compliance, and fail to present the appropriate risk information.
Now, as all you weathered FDA cowhands know – when it comes to DDMAC letters (and every other piece of FDA communication) – it’s very important to understand what’s in the letter as well as what is not.
These letters are about sponsored links. What does that mean? Sponsored links, as the DDMAC letters illustrate, are those links in the “sponsored” section of a web search (in the case of Google, these are the search results that appear on the upper right hand side of the page). Never more than a few lines, they are teasers. And, not to put too fine a point on it – they are paid for product marketing messages. They are advertisements.
The DDMAC letter to sanofis-aventis is particularly instructive on this point:
“Omission of Risk Information
Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug. Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the
materials. The sponsored links present the following claims (emphasis in original):
* PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD. See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com … “
So, DDMAC is making the point that sponsored links such as these are being considered as “reminder ads” gone wild.
Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.
Podium policy via Warning Letters is not a replacement for clear and concise guidance.
Okay, so wither “guidance?” Consider some official agency direction that is already on the books:
Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
Click Here to Read the Report
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
It’s not a leap of faith to understand the implications (and applications) of this relative to the concept of sponsored Google links.
For example, what about the concept of “clicking thorough” to full risk/benefit information? Let’s look to the GSK letter for that one. DDMAC writes:
“We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.”
Now, here’s where it becomes less clear. How will this impact regulatory perspectives on branded product websites? What about third party websites that have been constructed with grants (unrestricted or otherwise) from interested parties? What about links and websites for devices and diagnostics?
What about predictability?
Well, that’s harder than it sounds because regulators love ambiguity. Ambiguity is power. And that’s particularly true for DDMAC issues that quickly bump up against the First Amendment. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.
My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters. What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee.
(In fact, it should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion.)
Here’s something that isn’t opinion -- sending out Warning Letters isn’t guidance – it’s punitive regulatory action. It’s FDA acting tough without putting in the time and brainpower to explain how to address the perceived problem. That’s not what we need. That doesn’t advance the pubic health.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.
Predictability is power in pursuit of the public health.
Here is a video link to our friendly but fractious (and often funny) forensic foray.
It’s worth watching.
On another note, this is proof positive that two people who hold strong opposing views can have a robust debate that is disputatious, substantial and respectful.
The Center for Medicine in the Public Interest (the public policy institute home of drugwonks.com) is a member of the Health Policy Consensus Group, an affiliation of policy experts from major market-oriented think tanks and others who work together to advance patient-centered ideas for health reform.
That group has many ideas about how to move healthcare reform ahead in an expeditious and responsible way -- but our immediate concern is with many of the programs being both implemented and considered by the new administration.
First do no harm.
To that end we have issues the following statement:
__________________________________________________________
Would the health reform prescriptions offered
by President Obama and Congressional leaders help patients?
From the Health Policy Consensus Group
President Obama repeatedly has reassured the American people, “If you've got health care already, and probably the majority of you do, then you can keep your plan if you are satisfied with it. You can keep your choice of doctor.” Research shows 82 percent of Americans rate the health care they receive as good to excellent.
- A new government health insurance plan
- An employer "play-or-pay" mandate
- A uniform, government-defined package of benefits
- A mandate that individuals must purchase insurance
- A National Health Insurance Exchange extending federal regulatory powers over private insurance
- Federal interference in the practice of medicine through a federal health board, comparative effectiveness review, and other government intrusions into medical decision-making
As to why we explain below why we believe these ideas would diminish individual Americans’ freedom and control over their personal health decisions, please see the complete Statement on Health Reform here.
There are many problems that need to be addressed in the health sector, and the signatories to this statement have written extensively about our ideas for reform. Because the reform agenda is moving rapidly through Congress, we believe the American public should be aware of the likely impact of the policies described in this statement which are under active consideration by elected leaders.
We believe that the proposals put forth by the Administration and Congressional leaders would harm, not help, patients and would not fulfill the goals and promises made to the American people.
Biotech gets short shrift from Obama
His policies don't support entrepreneurial medical innovation.
By ROBERT GOLDBERG
Vice president, Center for Medicine in the Public Interest
President Barack Obama said last month that small businesses "are the heart of the American economy." He promised his administration would do everything it could to help entrepreneurs since they were the "core of America's story."
Yet, Obama's policies are threatening biotechnology – one of the most vibrant and important forms of small business our nation has ever produced.
Medical innovations have added wealth and health to our nation. From 1970-2000, increased longevity added approximately $3.2 trillion per year to national wealth, the equivalent of half of the average annual gross domestic product over the period.
According to a 2004 study by the Milken Institute, biopharmaceutical companies are responsible for creating over 2.7 million jobs across the United States. The industry was directly responsible for $63 billion in real output in 2003 and a total output of over $172 billion when its ripple effect is figured in across other sectors.
The president has increased federal funding for basic research and stem-cell science. With $20 billion a year in research funding, the National Institute of Health is important. But to translate discoveries into treatments will require more than the nearly $60 billion in money currently being invested by pharmaceutical, biotech and venture capital firms on cutting-edge treatments for cancer, Alzheimer's, AIDS, mental illness and heart disease.
That investment is (in real dollars) declining. Less than half of all public biotech firms have six months of cash left for research. For startups the situation is direr, even though the scientific promise of their investment is great.
Yet at every step of the way, President Obama supports policies that will stifle the entrepreneurship that he praises, and which are vital to actually producing real cures.
Obama supports de facto price controls that would allow the "reimportation" of prescription drugs. In essence, this is an effort to force every pharmaceutical and biotech company to sell drugs here at the controlled prices imposed in Canada and Europe.
Yet these are the same price controls that shut down medical innovation in those nations – companies sell their wares there for a small profit, but they don't risk the money to develop new lifesavers for those markets. If reimportation worked to force down prices here, it would also shut down the innovation Obama claims to favor.
Obama is establishing a comparative effectiveness council to slow down the introduction of new medical technologies. This entity would, like similar agencies in England and elsewhere, allows economists to compare old treatments with new ones and then tell doctors how much someone's life is worth – and whether it's worth saving – in order to save money.
The impact on innovation and patient well-being should be obvious. The UK's comparative effectiveness panel said new cancer pills were more effective than debilitating chemo treatments and extended life but still weren't worth paying for. No wonder the UK biotech industry issued a report blaming comparative effectiveness for killing not only people but the incentive for innovation.
Obama wants to apply comparative effectiveness to Medicare and eventually to every health plan. This would delay and ration the elderly's use of breakthrough drugs and ultimately let the government control what drugs and treatments everyone can take. In Europe, over the past 10 years, similar restrictions have caused the development of new drugs to stall. From 1993-97, Europe launched 81 breakthrough drugs; from 1998-2002, just 44. Meanwhile, U.S. drug launches jumped from 48 to 85.
Finally, it is disappointing that Obama made food safety, not medical progress, his number one concern in reforming the Food and Drug Administration. Indeed, Obama added money to the FDA's budget to inspect spinach but not to speed up the approval of breakthrough drugs for spinal cord injuries, multiple sclerosis and rare diseases. The agency has a program using 21st-century science – such as gene and stem cell-based tests – to determine if new medicines work. But Obama has refused to add money for that effort. You can score more political points sticking it to drug and biotech companies than standing shoulder to shoulder with dying patients.
Together, these policies are draining the life out of the biotechnology industry. The president is investing in "green" technologies to promote the environment. Yet, his health care policies will undermine private sector investment in medical innovations critical to solving public health problems related to the aging and growth of the world's population.
For all his rhetoric, thanks to his policies the medical discoveries the president supports will never be translated into economic prosperity or treatments that transform humanity.
Click Here to Read the Full Article
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
